The instruction for medical use
the Trade name
the International unlicensed
name Clotrimazolum Dosage Form 1% Cream Structure of 100 G of Cream contain
active agent – Clotrimazolum of 1 g,
excipients: cetostearyl alcohol, octyllauryl alcohol, polysorbate 60, sorbitan stearate, spermaceti synthetic, benzyl alcohol, the water purified.
Homogeneous mass of white color
Anti-infectious and antiseptic drugs for use in gynecology. Imidazole derivatives. Clotrimazolum.
The ATX G01AF02 code
Pharmacokinetics Later properties of putting cream Clotrimazolum on skin, Clotrimazolum is absorbed by epidermis. Higher concentrations of Clotrimazolum are in horn and acanthceous layers of epidermis and also in nipples and a mesh layer of a derma. Clotrimazolum is badly soaked up through skin and mucous membranes and has practically no systemic action.
Clotrimazolum is metabolized in a liver to the inactive substances removed with urine and excrements.
the action Mechanism
Clotrimazolum suppresses growth and cell fission. In small concentration works fungistaticly, in big – it is fungicidal. The anti-mycotic effect of Clotrimazolum is connected with disturbance of synthesis of the ergosterol which is a part of a cellular membrane of mushrooms and linking with phospholipids of a cell wall of a mushroom.
Clinical trials showed that the effect at use of Clotrimazolum is similar to effect of use of derivatives of an imidazole – to an econazol and a ketokonazol.
In a fungal cell Clotrimazolum also inhibits biosynthesis of protein, fats, DNA and polysaccharides, destroys cellular nucleic acids and increases potassium loss. Can suppress activity of enzymes and biosynthesis of triglycerides and phospholipids in a cell wall. In high concentrations Clotrimazolum leads to damage of a cellular membrane by means of the mechanisms independent of synthesis of sterols.
Clotrimazolum used for treatment of the infections caused by C.albicans suppresses transformation blastofor in its invasive form. Changes in structure of a cellular membrane lead of cells to death. Extent of influence of drug depends on degree of susceptibility of a microorganism to Clotrimazolum.
The activity range
Clotrimazolum is characterized by a wide range of antifungal and antimicrobial action, suppresses growth and carries out to death of dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum), yeast-like mushrooms (Candida sp., Cryptococcus neoformans), dimorphous mushrooms (Coccidioides immitis, Histoplasma capsulatum, Paracoccidicides brasiliensis) and a protozo (Trichomonas vaginalis).
Clotrimazolum has antimicrobic effect concerning gram-positive microorganisms.
In vitro Clotrimazolum possesses broad fungistatic and fungicide action. Its effect on dermatophytes is similar to the effect rendered by griseofulvin, and on sort Candida organisms – polyenes (amfotetsin In and nystatin).
In concentration lower than 1 mkg/ml Clotrimazolum suppresses the majority of strains of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis.
In concentration from 3 mkg/ml Clotrimazolum suppresses growth of the majority of bacteria: Pitorosporum orbiculare, Aspergillus fumigatus, Candida species, including Candida albicans, some strains of Staphylococcus aureus, Streptococcus pyogenis, and also some strains of Proteus vulgaris and Salmonella. Clotrimazolum is active against Sporotrix, Cryptococcus, Cefalosporium and Fusarium. Concentration higher than 100 mkg/ml are effective against Trichomonas vaginalis.
Clotrimazolum-resistant strains meet extremely seldom, the only described strain characteristic resistance – Candida guilliermondi.
There are no reports on resistance among the strains sensitive to Clotrimazolum, after crops of Candida albicans and Trichophyton mentagrophytes. The resistance to Clotrimazolum at strains of C was not observed. albicans with a rezistentonost to half-yen antibiotics.
– topical treatment of skin infections of surfaces of hands, feet, bodies, shins and legs caused by dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis)
– the chromophytosis caused by Malassezia furfur (Pityrosporum orbiculare or Pityrosporum ovale)
– barmy infections (including the sort Candida and balanitis) integuments and mucous external genitals (vulvar lips, a prepuce)
the Route of administration and doses
Only for external use.
Cream is applied with a thin layer on affected areas of skin by 2-3 times a day and carefully rub (skin is previously cleaned by means of soap with a neutral rn and get wet with a dry towel).
Duration of treatment is from 2 to 4 weeks and depends on disease severity, localization of pathological changes and efficiency of therapy.
All infected areas have to be processed at the same time.
In order to avoid a recurrence cream Clotrimazolum is recommended to continue therapy not less than 2 weeks after disappearance of symptoms of a disease.
Treatment of dermatomycoses is carried out by not less than 4 weeks.
Treatment of the infections caused by Candida – at least 2 weeks.
The chromophytosis is effectively treated at topical administration within 1-3 weeks.
If symptoms of a disease do not decrease after 7 days of use, it is necessary to consult with the doctor.
the Frequency of manifestation of side effects of drug is defined as follows:
Very often (≥1/10), it is frequent (≥1/100 and & lt, 1/10), infrequently (≥1/1000 and & lt, 1/100), is rare (≥1/10000 and & lt, 1/1000), is very rare (& lt, 1/10000), it is unknown (not enough data for assessment).
– contact allergic dermatitis, an erythema
– allergic reactions (urticaria, short wind, hypotension, unconscious states)
– an itching, rash, blisters, peeling of skin, discomfort/pain in the site of application, burning, hypostasis, irritation
of the Contraindication
– hypersensitivity to active ingredient or any component of drug
Preaparat can have negative impact on latex contraceptives, damaging them and reducing their contraceptive ability. Patients have to use alternative methods of contraception at least for five days after the termination of a course of therapy by the drug Clotrimazolum.
Intravaginalny use of the drug Clotrimazolum and drug takrolimus for intake (FK-506, immunosuppressant) can lead to increase in level of a takrolimus in blood plasma in this connection patients have to be under careful observation of the doctor regarding emergence of symptoms of overdose takrolimusy and, as necessary, definitions of its concentration in plasma.
it is not recommended to use the drug Clotrimazolum in an eye area. To avoid hit in eyes!
As a part of drug there is a cetostearyl alcohol that can cause local irritation of skin (contact dermatitis).
there Is a limited amount of data on Clotrimazolum use by pregnant women. Researches do not indicate animals straight lines or indirect harmful effects connected with reproductive toxicity. As a precautionary measure it is preferable to avoid use of Clotrimazolum during the first trimester of pregnancy.
the toxicological data which are Available pharmakodinamicheskiye/on animals showed discharge of Clotrimazolums/metabolites in milk. During treatment by Clotrimazolum feeding by a breast is not recommended.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Clotrimazolum cream does not affect or has insignificant impact on ability to run the vehicle or potentially dangerous mechanisms.
Overdose by drug is improbable in connection with a dosage form, a form of introduction and low absorption of Clotrimazolum.
Symptoms: in case of unforeseen use of drug the dizziness, nausea, vomiting are inside possible.
Treatment: there is no specific antidote. If necessary – symptomatic treatment.
Form of release and packing
Cream of 1%.
On 20 g of cream place in tubas aluminum with internal varnish coating, sealed by membranes and closed by the screw-on plastic covers.
On 1 tuba together with the instruction for use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 25 ºС. Not to freeze.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
the Producer GlaksoSmitKlyayn Pharmasyyutikalz S.A., Poland
(189 Grunwaldzka Street, 60-322 Poznan)
the Owner of the registration certificate
S.A. GlaksoSmitKlyayn Pharmasyyutikalz, Poland
(189 Grunwaldzka Street, 60-322 Poznan)
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Predstavitelstvo kompanii GlaksoSmitKlyayn Export Ltd in
Kazakhstan 050059, Almaty, Furmanov St., 273
Phone number: +7 701 9908566, +7 727 258 28 92, +7 727 259 09 96
Fax number: + 7 727 258 28 90
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